Laparoscopic versus open total mesorectal excision for rectal cancer

Sandra Vennix; Loeki Pelzers; Nicole Bouvy; Geerard L. Beets; Jean‐Pierre Pierie; Theo Wiggers; Stephanie Breukink

doi:10.1002/14651858.CD005200.pub3

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Figure 1

Study selection flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Forest plot of comparison: 2 Survival and recurrences, outcome: 2.1 Disease free survival.

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Figure 4

Forest plot of comparison: 4 Short term morbidity and mortality, outcome: 4.1 30d morbidity (total).

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Figure 5

Forest plot of comparison: 5 Post op recovery, outcome: 5.3 Hospital stay.

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Analysis 1.1

Comparison 1 Survival and recurrences, Outcome 1 Disease‐free survival.

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Analysis 1.2

Comparison 1 Survival and recurrences, Outcome 2 Overall survival.

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Analysis 1.3

Comparison 1 Survival and recurrences, Outcome 3 Local recurrences.

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Analysis 1.4

Comparison 1 Survival and recurrences, Outcome 4 Distant recurrences.

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Analysis 1.5

Comparison 1 Survival and recurrences, Outcome 5 Wound/port site metastases.

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Analysis 2.1

Comparison 2 Surgical data, Outcome 1 Lymph nodes retrieved.

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Analysis 2.2

Comparison 2 Surgical data, Outcome 2 CRM positivity.

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Analysis 2.3

Comparison 2 Surgical data, Outcome 3 Duration of surgery.

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Analysis 2.4

Comparison 2 Surgical data, Outcome 4 Incision length.

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Study
Araujo 2003	0 (0/13)
Braga 2007	7.2 (6/83)
COLOR 2 a 2013	17 (121/695)
Hong Kong a 2004	23.2 (47/203)
Kang 2010	1.2 (2/170)
King 2006	7.3 (3/41)
Liang 2011	0.5 (1/169)
Liu 2010	0 (0/98)
Lujan 2009	7.9 (8/101)
MRC CLASICC a 2005	33.9 (82/242)
Ng 2008	9.8 (5/51)
Pechlivanides 2007	2.9 (1/34)
Zhou 2004	Unknown
Zhou 2007	Unknown

Analysis 2.5

Comparison 2 Surgical data, Outcome 5 Conversion rate.

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Analysis 2.6

Comparison 2 Surgical data, Outcome 6 Blood loss.

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Analysis 2.7

Comparison 2 Surgical data, Outcome 7 Transfusion requirement.

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Analysis 2.8

Comparison 2 Surgical data, Outcome 8 Intraoperative morbidity.

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Analysis 3.1

Comparison 3 Short‐term morbidity and mortality, Outcome 1 30‐day morbidity (total).

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Analysis 3.2

Comparison 3 Short‐term morbidity and mortality, Outcome 2 Wound infection.

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Analysis 3.3

Comparison 3 Short‐term morbidity and mortality, Outcome 3 Bleeding.

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Analysis 3.4

Comparison 3 Short‐term morbidity and mortality, Outcome 4 Urinary complications.

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Analysis 3.5

Comparison 3 Short‐term morbidity and mortality, Outcome 5 Pneumonia.

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Analysis 3.6

Comparison 3 Short‐term morbidity and mortality, Outcome 6 Anastomotic leakage.

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Analysis 3.7

Comparison 3 Short‐term morbidity and mortality, Outcome 7 Need for reoperation.

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Analysis 3.8

Comparison 3 Short‐term morbidity and mortality, Outcome 8 30‐day mortality.

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Analysis 4.1

Comparison 4 Postoperative recovery, Outcome 1 Analgesia use (number of doses).

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Analysis 4.2

Comparison 4 Postoperative recovery, Outcome 2 Day 1 pain score (VAS).

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Analysis 4.3

Comparison 4 Postoperative recovery, Outcome 3 Hospital stay (days).

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Analysis 4.4

Comparison 4 Postoperative recovery, Outcome 4 Time to normal diet (days).

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Analysis 4.5

Comparison 4 Postoperative recovery, Outcome 5 Time to first defecation (days).

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Analysis 5.1

Comparison 5 Long term morbidity, Outcome 1 Incisional hernia.

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Analysis 5.2

Comparison 5 Long term morbidity, Outcome 2 Intestinal obstruction.

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Summary of findings for the main comparison. Laparoscopic versus open total mesorectal excision for rectal cancer

Laparoscopic versus open total mesorectal excision (TME) for rectal cancer
Patient or population: people with Rectal Cancer Settings: Intervention: Laparoscopic TME Comparison: Open TME
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)
	Assumed risk	Corresponding risk
	Open TME	Laparoscopic TME
Disease‐free survival at 5 years	718 per 1000	722 per 1000 (659 to 778)	OR 1.02 (0.76 to 1.38)	943 (4 studies)	⊕⊕⊕⊝ moderate¹
Overall survival at 5 years	679 per 1000	709 per 1000 (648 to 763)	OR 1.15 (0.87 to 1.52)	987 (4 studies)	⊕⊕⊕⊝ moderate²
Local recurrences	54 per 1000	48 per 1000 (31 to 73)	OR 0.89 (0.57 to 1.39)	1538 (8 studies)	⊕⊕⊕⊝ moderate³
Lymph nodes retrieved		The mean number of lymph nodes retrieved in the intervention groups was 0.43 lower (1.13 lower to 0.26 higher)		3682 (11 studies)	⊕⊕⊕⊕ high
CRM positivity	61 per 1000	60 per 1000 (44 to 83)	OR 0.99 (0.71 to 1.4)	2313 (8 studies)	⊕⊕⊕⊝ moderate⁴
30‐day morbidity (total)	275 per 1000	263 per 1000 (233 to 295)	OR 0.94 (0.8 to 1.1)	3397 (11 studies)	⊕⊕⊕⊝ moderate⁵
Hospital stay (days)		The mean length of hospital stay in the intervention groups was 2.16 days shorter (3.22 to 1.1 days shorter)		3084 (11 studies)	⊕⊕⊕⊝ moderate⁶
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; OR: Odds ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹Statistical inaccuracy with wide confidence interval at both sides ²Statistical inaccuracy with wide confidence interval at both sides, but a tendency for a higher overall survival for LTME ³Statistical inaccuracy with wide confidence interval at both sides, but a tendency for a lower recurrence rate for LTME ⁴Only 8 studies provided data on CRM positivity ⁵Definition of overall morbidity varied or was unclear ⁶Length of hospital stay depends on postoperative protocols and implementation of enhanced recovery programmes

Summary of findings for the main comparison. Laparoscopic versus open total mesorectal excision for rectal cancer

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Table 1. Reported outcomes

Study ID

Long‐term survival

30‐day mortality

30‐day morbidity

Long‐term morbidity

Lymphnodes

Gastrointestinal recovery

Pain

Bleeding

Length of hospital stay

Immune response

Quality of life

Cost

Araujo 2003

‐

Braga 2007

168

5y/3y

‐

COLOR 2 a 2013

1044

‐

COLOR 2 b 2011

‐

Hong Kong a 2004

403

‐

Hong Kong b 2009

153

10y

‐

Hong Kong c 2000

‐

Hong Kong d 2003

‐

Kang 2010

340

‐

King 2006

‐

Liang 2011

343

‐

Liu 2010

186

‐

Lujan 2009

204

‐

MRC CLASICC a 2005

381

10y/5y/3y

‐

MRC CLASICC b 2005

148

‐

MRC CLASICC c 2001

236

‐

Ng 2008

‐

Pechlivanides 2007

‐

Zhou 2004

171

‐

Zhou 2007

‐

Table 1. Reported outcomes

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Comparison 1. Survival and recurrences

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Disease‐free survival Show forest plot	5		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 10‐year	1	130	Odds Ratio (M‐H, Fixed, 95% CI)	1.25 [0.51, 3.06]
1.2 5‐year	4	943	Odds Ratio (M‐H, Fixed, 95% CI)	1.02 [0.76, 1.38]
1.3 3‐year	1	326	Odds Ratio (M‐H, Fixed, 95% CI)	1.08 [0.67, 1.74]
2 Overall survival Show forest plot	6		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 10‐year	2	534	Odds Ratio (M‐H, Fixed, 95% CI)	1.15 [0.80, 1.65]
2.2 5‐year	4	987	Odds Ratio (M‐H, Fixed, 95% CI)	1.15 [0.87, 1.52]
2.3 3‐year	2	682	Odds Ratio (M‐H, Fixed, 95% CI)	1.00 [0.70, 1.42]
3 Local recurrences Show forest plot	8	1538	Odds Ratio (M‐H, Fixed, 95% CI)	0.89 [0.57, 1.39]

3.1 5‐year	5	963	Odds Ratio (M‐H, Fixed, 95% CI)	0.94 [0.49, 1.81]
3.2 3‐year	3	575	Odds Ratio (M‐H, Fixed, 95% CI)	0.84 [0.46, 1.56]
4 Distant recurrences Show forest plot	6	1341	Odds Ratio (M‐H, Fixed, 95% CI)	0.96 [0.70, 1.32]

5 Wound/port site metastases Show forest plot	7	2130	Odds Ratio (M‐H, Fixed, 95% CI)	2.76 [0.75, 10.20]

Comparison 1. Survival and recurrences

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Comparison 2. Surgical data

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lymph nodes retrieved Show forest plot	11	3682	Mean Difference (IV, Random, 95% CI)	‐0.43 [‐1.13, 0.26]

2 CRM positivity Show forest plot	8	2313	Odds Ratio (M‐H, Fixed, 95% CI)	0.99 [0.71, 1.40]

3 Duration of surgery Show forest plot	12	3840	Mean Difference (IV, Random, 95% CI)	37.48 [27.80, 47.15]

4 Incision length Show forest plot	4	1488	Mean Difference (IV, Random, 95% CI)	‐12.83 [‐14.87, ‐10.80]

5 Conversion rate Show forest plot			Other data	No numeric data

6 Blood loss Show forest plot	8	2615	Mean Difference (IV, Random, 95% CI)	‐101.78 [‐147.57, ‐55.98]

7 Transfusion requirement Show forest plot	5	939	Odds Ratio (M‐H, Fixed, 95% CI)	0.34 [0.19, 0.62]

8 Intraoperative morbidity Show forest plot	4	1618	Odds Ratio (M‐H, Fixed, 95% CI)	0.86 [0.62, 1.18]

Comparison 2. Surgical data

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Comparison 3. Short‐term morbidity and mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 30‐day morbidity (total) Show forest plot	11	3397	Odds Ratio (M‐H, Fixed, 95% CI)	0.94 [0.80, 1.10]

2 Wound infection Show forest plot	10	3337	Odds Ratio (M‐H, Fixed, 95% CI)	0.68 [0.50, 0.93]

3 Bleeding Show forest plot	5	1181	Odds Ratio (M‐H, Fixed, 95% CI)	0.30 [0.10, 0.93]

4 Urinary complications Show forest plot	8	1756	Odds Ratio (M‐H, Fixed, 95% CI)	1.23 [0.83, 1.81]

5 Pneumonia Show forest plot	8	2668	Odds Ratio (M‐H, Fixed, 95% CI)	1.32 [0.83, 2.09]

6 Anastomotic leakage Show forest plot	10	2505	Odds Ratio (M‐H, Fixed, 95% CI)	1.01 [0.73, 1.40]

7 Need for reoperation Show forest plot	7	2316	Odds Ratio (M‐H, Fixed, 95% CI)	0.82 [0.57, 1.20]

8 30‐day mortality Show forest plot	11	3812	Odds Ratio (M‐H, Fixed, 95% CI)	0.81 [0.50, 1.32]

Comparison 3. Short‐term morbidity and mortality

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Comparison 4. Postoperative recovery

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Analgesia use (number of doses) Show forest plot	5	1199	Std. Mean Difference (IV, Random, 95% CI)	‐0.60 [‐0.93, ‐0.27]

2 Day 1 pain score (VAS) Show forest plot	3	776	Mean Difference (IV, Fixed, 95% CI)	‐0.74 [‐1.04, ‐0.44]

3 Hospital stay (days) Show forest plot	11	3084	Mean Difference (IV, Random, 95% CI)	‐2.16 [‐3.22, ‐1.10]

4 Time to normal diet (days) Show forest plot	8	2109	Mean Difference (IV, Random, 95% CI)	‐0.52 [‐0.80, ‐0.23]

5 Time to first defecation (days) Show forest plot	8	2893	Mean Difference (IV, Random, 95% CI)	‐0.86 [‐1.17, ‐0.54]

Comparison 4. Postoperative recovery

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Comparison 5. Long term morbidity

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Incisional hernia Show forest plot	3	508	Odds Ratio (M‐H, Random, 95% CI)	0.84 [0.32, 2.21]

2 Intestinal obstruction Show forest plot	3	508	Odds Ratio (M‐H, Fixed, 95% CI)	0.30 [0.12, 0.75]

Comparison 5. Long term morbidity

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